Replimune Secures FDA Approval for TUDRIQEV and Raises $150 Million

What happened

On August 6, 2026, the FDA approved TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on PD-1 therapy. Replimune completed a $150 million financing and appointed Michelle DiNapoli as Chief Commercial Officer effective August 18, 2026.

Why it matters

The approval marks a defining milestone for Replimune, transforming it into a fully integrated biotechnology company. The financing extends the cash runway to support the commercial launch of TUDRIQEV and the ongoing IGNYTE-3 confirmatory trial.